medical Class II Updated 2019-05-08

BioFire Diagnostics, LLC recalls FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire

Recalled Product

FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

Hazard / Issue

Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots with an expiration date of 23 October 2019 onward
View official government recall

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